Developing Viability Index for Machine Perfused Livers

Development of a Liver Viability Index for Transplantation

Machine perfusion technology is nearing the point of rescuing discarded liver grafts in the hope of proving them to be or improving them to the point of being transplantable. However, there are no validated metrics to determine transplantability after machine perfusion. This study involves collecting biopsies from transplanted livers before and after implantation to correlate metabolite and gene expression with post-transplant function. This data will help develop a viability index for machine perfused livers.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhoses
• Intervention / Treatment: Diagnostic test: Liver Biopsy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi Yeh, MD; Phone Number: 617-726-3664; Email: hyeh@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Heidi Yeh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female 18-75 years of age.
• Candidate for a deceased-donor liver allograft.

Exclusion Criteria:

• Seropositivity for HIV-1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Biopsy; Biopsies taken at protocol specified time points

Diagnostic test: Liver Biopsy; For measurement of tissue co-factor levels, we will take needle biopsies of transplanted livers immediately after procurement, immediately prior to implantation (at the end of preservation), 30 minutes after portal vein reperfusion, and 30 minutes after hepatic artery reperfusion. For those livers that have more than 60 minutes between portal vein and hepatic artery reperfusion, an additional biopsy will be performed at 60 minutes after portal vein reperfusion. Post-procurement biopsies will be collected regardless of where the liver was obtained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak transaminase value post transplant	The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury	1 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
Acute Liver Rejection	1 Year
Incidence of major Infection	1 Year
Hepatitis C Recurrence (in Hepatitis C positive recipients)	1 Year
Kidney Failure	1 Year
Biliary Complications	1 Year
Liver Graft Failure	1 Year
Death	1 Year

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Brigham and Women's Hospital; Shriners Hospitals for Children
• Investigators: Principal Investigator: Heidi Yeh, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 31, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: Liver Perfusion ATP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No